药明生物4.5亿美元授权英国OBT公司使用创新平台WuXiBody™开发5个双抗
(*Please scroll down for English news.)
中国上海和英国牛津，2018年12月11日
全球领先的开放式生物制药技术平台公司药明生物（WuXi Biologics, 2269.HK）今日宣布，与肿瘤免疫和抗体偶联药物（ADC）领域拥有多个临床阶段产品线的英国生物技术公司Oxford BioTherapeutics（OBT）进一步深化战略合作，授权其使用药明生物具有自主知识产权的WuXiBody™双特异性抗体开发平台开发五个全新双特异性抗体。
OBT公司首席执行官Christian Rohlff博士（左）和药明生物首席执行官陈智胜博士（右）握手庆祝达成合作
通过此次合作，OBT公司将借助药明生物在双特异性抗体领域的丰富经验，充分发挥自身在药物发现与开发方面的优势，开发和商业化新一代肿瘤抗体药物。根据该战略合作协议，OBT公司获授权使用药明生物已申请专利的WuXiBody™技术平台，借力该平台推进五个双特异性抗体的研发及商业化进程；药明生物将获得平台授权首付款、产品批准注册和商业化里程碑付款，总金额最高可达4.5亿美元，以及产品上市后按全球销售额计算的销售提成。
“我们在肿瘤免疫领域与药明生物达成战略合作对公司发展而言至关重要，基于WuXiBody™技术平台和PD-L1技术合作，将助力我们深耕和拓宽公司一流的肿瘤免疫研发管线。”OBT公司首席执行官Christian Rohlff博士表示，“我们非常高兴借助WuXiBody™技术，将OBT公司第二代肿瘤免疫创新药物与主流免疫检查点抑制剂结合，从而有望开发出在实体瘤和血液肿瘤拥有广泛适应症的创新药，为无法从现有肿瘤免疫产品中获益的患者带来新的治疗方案。使用创新双抗平台WuXiBody™能够集多种治疗手段的优势于一个药物，优化新药风险收益比、降低研发成本以及最优化产品的潜在商业价值。此次合作将使公司的产品开发策略在肿瘤免疫治疗领域中脱颖而出，研发出有望改变肿瘤治疗领域未来版图的关键性产品，助力OBT实现‘治愈癌症’的目标。”
“我们很高兴借助WuXiBody™平台进一步深化与OBT公司的战略合作伙伴关系，这是该平台今年九月全球亮相以来达成的第三项战略合作。”药明生物首席执行官陈智胜博士表示，“公司具有自主知识产权的双特异性抗体开发平台WuXiBody™广受合作伙伴认可充分彰显了其强劲实力，不仅突破了同类技术平台的局限性，同时还具有显著降低双特异性抗体生产成本等优势。目前已开发的双特异性抗体表达量最高16g/L，并且达到一步Protein A纯化后纯度和收率均超过95%的技术指标。我们将持续致力于投资开发全球领先的创新技术，实现加快和变革生物药开发和生产进程的愿景。”
关于WuXiBody™
WuXiBody™是药明生物具有自主知识产权的双特异性抗体技术平台，有望成为业界最好的双特异性抗体平台之一。该平台突破了绝大多数双特异性抗体平台技术瓶颈，有效克服了双特异性抗体开发过程中表达量低、多聚体高、纯化收率低等挑战，具有为每个项目节约6到18个月研发时间以及显著降低双特异性抗体生产成本等优势。目前已开发的双特异性抗体表达量最高达16g/L，并且达到一步Protein A纯化后纯度和收率均超过95%。同时，WuXiBody™平台还兼具独特的灵活性，可以构建各种不同的价数（如二价、三价或四价双特异性抗体）和结构，以满足不同项目的生物学特性需求。
关于Oxford BioTherapeutics
OBT是一家针对肿瘤领域未被满足临床需求开发全新肿瘤免疫疗法及抗体偶联药物（ADC）的临床阶段公司，总部位于英国牛津，在美国圣何塞设有分公司。OBT开发的肿瘤免疫疗法为免疫细胞突触理论提供了独创洞见，并已确定了数个治疗癌症的新候选药物。
OBT公司研发管线中两个领先的临床项目分别是MEN1112（OBT357）和MEN1309（OBT076）。前者是一个靶向CD157（在急性髓系白血病细胞和白血病干细胞中表达）的单抗候选药物，目前处于临床I期剂量递增试验阶段，用于治疗复发/难治性急性髓系白血病（AML）；后者是一个靶向CD205的DM4抗体偶联药物（ADC），用于治疗转移性三阴乳腺癌、膀胱癌和胰腺癌以及非霍奇金淋巴瘤。目前MEN1309（OBT076）也在欧盟进行临床I期剂量递增试验。
OBT的产品管线和开发能力已经通过与全球抗体开发领域领导者的多个战略合作得到验证，包括公司如Seattle Genetics、安进、Alere、BioWa、百时美施贵宝（Medarex）和欧洲制药公司Menarini，这些合作为公司这两个项目在欧盟开展的临床Ⅱ期概念验证试验提供了充裕的资金支持，公司同时保留了产品在北美和日本市场的商业化权益。此外，勃林格殷格翰也是公司两个临床前阶段项目的合作伙伴。OBT拥有一支专注于肿瘤领域的强大管理团队和董事会，他们在开发肿瘤免疫疗法和抗体疗法方面拥有丰富经验。如需更多信息，请访问www.oxfordbiotherapeutics.com。
关于药明生物
药明生物（股票代码：2269.HK）作为一家香港上市公司，是全球领先的开放式、一体化生物制药能力和技术赋能平台。公司为全球生物制药公司和生物技术公司提供全方位的端到端研发服务，帮助任何人、任何公司发现、开发及生产生物药，实现从概念到商业化生产的全过程，加速全球生物药研发进程，降低研发成本，造福病患。截至2018年6月30日，在药明生物平台上研发的综合项目达187个，包括98个处于临床前研究阶段，78个在临床早期（I期，II期）阶段，10个在后期临床（III期）以及1个在商业化生产阶段。预计到2021年，公司在中国、爱尔兰、新加坡、美国规划的生物制药生产基地合计产能约22万升，这将有力确保公司通过健全强大的全球供应链网络为客户提供符合全球质量标准的生物药。如需更多信息，请访问：www.wuxibiologics.com.cn。
相关阅读
药明生物与腾盛博药针对全新双特异抗体免疫疗法达成独家研发合作
Oxford BioTherapeutics Expands Strategic Collaboration with WuXi Biologics and Licenses WuXiBody™ Platform for Five Bispecific Antibody Programs for up to $450 Million
SHANGHAI, China and OXFORD, UK
December 11, 2018
WuXi Biologics (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing and Oxford BioTherapeutics Ltd. ("OBT"), a clinical stage oncology company with a pipeline of immuno-oncology and antibody-drug conjugate based therapies, today announced the expansion of their strategic and innovative immuno-oncology (IO) alliance through which OBT will research, develop and commercialize five novel bispecific antibodies for the treatment of several cancer types using WuXi Biologics' proprietary WuXiBody™ Platform.
Dr. Christian Rohlff, Chief Executive Officer of Oxford BioTherapeutics and Dr. Chris Chen, Chief Executive Officer of WuXi Biologics
The deal brings together OBT's target discovery and development expertise with WuXi Biologics' extensive expertise in developing world-class bispecific antibodies, to build value for both companies as OBT works to develop and commercialize this exciting portfolio of potential next-generation antibody-based cancer drugs. WuXi Biologics will receive an upfront payment as well as potential development, regulatory and commercial milestone payments up to $450 million, and will be entitled to royalties based on global sales of these bispecific antibodies.
"Our immuno-oncology (IO) collaboration with WuXi Biologics, around the WuXiBody™ bispecific platform and clinical mid-stage PDL1 antibody, is a significant step for OBT to deepen and broaden our exciting first-in-class IO pipeline," said Dr. Christian Rohlff, Chief Executive Officer of Oxford BioTherapeutics. "Combining OBT's novel second generation IO medicines with a major check-point pathway into a single entity, with potential broad utility across many solid and liquid tumor types, is designed to generate novel therapies for patients who do not benefit from the existing IO medicines. Novel products from this collaboration, which combine multiple treatment modalities into a single agent, will improve the risk/benefit ratio, reduce costs and optimize future commercial potential. This deal will allow us to clearly differentiate our product development strategies from existing IO therapies and to generate products that will play a key role in shaping the future treatment landscape for oncology. Products from this deal are expected to play a key role in OBT's commitment to curing cancer."
"We are excited to expand our strategic partnership with OBT to include the proprietary WuXiBody™ platform. This is the 3rd partnership we signed since we globally launched this exciting platform this September," said Dr. Chris Chen, Chief Executive Officer of WuXi Biologics. "Quick adoption of our proprietary WuXiBody™ bispecific platform further validates our beliefs that this platform addresses most technical limitations of current bispecific platforms and can potentially tremendously reduce the cost of making these biologics. We have achieved 16g/L in cell culture titer, 95+% purity after one-step Protein A purification and 95+% step yield for Protein A step. WuXi Biologics will continue to invest to develop next-generation globally leading technologies to transform biologics discovery, development and manufacturing."
About WuXiBody™ Platform
WuXiBody™, a proprietary bispecific antibody platform of WuXi Biologics, is potentially the Best-in-Class bispecific platform in the field. It can effectively break through the CMC barriers of bispecific antibodies development, expedite the process by 6-18 months and significantly reduce manufacturing cost, a severe limitation of other current bispecific platforms. WuXiBody™ bispecifics have achieved 16g/L in cell culture titer, 95+% purity after one-step Protein A purification and 95+% yield for Protein A step. WuXiBody™ Platform enables almost any mAb sequence pairs to be assembled into bispecific constructs. They are characterized as low immunogencity, long in vivo half-life like mAbs and excellent stability. WuXiBody™ Platform also owns its unique structural flexibility, which makes it convenient to build various formats with different valency (2, 3 or 4 binding sites) to meet the requirements of different bispecific targets.
About Oxford BioTherapeutics
OBT is a clinical stage oncology company; based in Oxford, UK and San Jose, USA; with a pipeline of first-in-class immuno-oncology (IO) and antibody-drug conjugate (ADC) based therapies to fulfill major unmet patient needs in the field of cancer. OBT's IO discovery process provides unique insight into the cancer - immune cell synapse, and has identified several novel IO candidates for cancer therapy.
OBT's first two clinical programs are (1) MEN1112 (OBT357), an antibody-dependent cell-mediated cytotoxicity (ADCC) candidate targeting Bst1/CD157-expressing AML blasts & leukemic stem cells, currently in a phase I dose escalation trial for relapsed/refractory Acute Myeloid Leukemia and (2) MEN1309 (OBT076), a DM4 ADC targeting CD205 in triple-negative metastatic breast cancer, bladder and pancreatic cancers as well as Non-Hodgkin Lymphoma. MEN1309 (OBT076) is currently also in a EU phase I dose escalation trial.
OBT's pipeline and development capabilities have been validated through multiple strategic partnerships including with world leaders in antibody development (such as Seattle Genetics, Amgen, Alere, BioWa and BMS (Medarex)) and with leading European pharmaceutical company Menarini, which fully funds the clinical development of two programs in the EU to completion of phase II proof-of-concept, while OBT retains North American and Japan commercial rights. Additionally, two pre-clinical stage programs are partnered with Boehringer Ingelheim. OBT has a strong oncology focused management team and board with significant experience in developing IO and antibody-based therapies. For more information on Oxford BioTherapeutics, please visit www.oxfordbiotherapeutics.com.
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is the only open-access biologics technology platform in the world offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and value proposition to our global clients. As of June 30, 2018, there were a total of 187 integrated projects, including 98 projects in pre-clinical development stage, 78 projects in early-phase (phase I and II) clinical development, 10 projects in late-phase (phase III) development and 1 project in commercial manufacturing. With total estimated capacity of biopharmaceutical production planned in China, Ireland, Singapore and US reaching 220,000 liters by 2021, we will provide our biomanufacturing partners with a robust and premier-quality global supply chain network. For more information on WuXi Biologics, please visit www.wuxibiologics.com.
注：本信息不构成药明生物的信息披露或投资建议
